A digital pill intervention for HIV prevention in men with substance use disorder
SmartSteps: A Context-Aware, Pre-Exposure Prophylaxis Adherence Intervention for Individuals With Substance Use Disorder
PHASE3 · Brigham and Women's Hospital · NCT05378399
This study is testing a digital pill and smartphone app to help HIV-negative men who use drugs remember to take their daily prevention medication for 60 days.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Brigham and Women's Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05378399 on ClinicalTrials.gov |
What this trial studies
This study focuses on HIV-negative men who have sex with men (MSM) with substance use disorder, utilizing a digital pill system to enhance adherence to Pre-Exposure Prophylaxis (PrEP). Participants will take a daily digital pill for 60 days while using a smartphone app to track their adherence and report reasons for any missed doses. The study aims to collect data on smartphone usage and the context of nonadherence to improve future interventions. Participants will undergo several visits for assessments, including blood tests to measure PrEP adherence.
Who should consider this trial
Good fit: Ideal candidates are HIV-negative cisgender men aged 18 or older who have sex with men and are either initiating or currently on PrEP.
Not a fit: Patients who do not speak English or have a history of certain gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve PrEP adherence among individuals with substance use disorder, thereby reducing the risk of HIV infection.
How similar studies have performed: Other studies have shown promise in using digital health interventions for medication adherence, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 or older 2. Cisgender male 3. Has sex with men 4. HIV negative 5. On PrEP or initiating PrEP (including switching from 2-1-1 or "on-demand" PrEP dosing to once-daily dosing) 6. Moderate risk score on ASSIST substance use screener (11-26 for alcohol, 4-26 for all other substances) or higher 7. Qualifying laboratory testing for PrEP: Cr clearance in past 3 months, HBV vaccination, liver function tests 8. Owns a smartphone with Android or iOS Exclusion Criteria: 1. Does not speak English 2. History of Crohn's disease or ulcerative colitis 3. History of gastric bypass or bowel stricture 4. History of GI malignancy or radiation to abdomen 5. Allergy to gelatin, silver, or zinc (components of digital pill) 6. Allergy to PrEP 7. Not willing to operate DPS or Beiwe app
Where this trial is running
Boston, Massachusetts
- Fenway Health — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Peter R Chai, MD MMS — Brigham and Women's Hopsital
- Study coordinator: Peter R Chai, MD MMS
- Email: pchai@fenwayhealth.org
- Phone: 617-732-5640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV Infections, Substance Use, Adherence, Medication, Adherence, Treatment, Pre-Exposure Prophylaxis, Digital Pill System, Adherence, HIV Prevention